FDA 510(k)

gel-e Bandage

K-Number: K172010 · 2017-12-07

ApplicantGel-E, Inc. (Formerly Remedium Technologies, Inc.)

Decision Date2017-12-07

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

gel-e Bandage is the device name listed in this FDA 510(k) record. The listed applicant is Gel-E, Inc. (Formerly Remedium Technologies, Inc.). It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172010. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gel-e Bandage?

gel-e Bandage is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Gel-E, Inc. (Formerly Remedium Technologies, Inc.). The 510(k) number is K172010.

When did gel-e Bandage receive FDA 510(k) clearance?

gel-e Bandage received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172010.

Who is the listed applicant for gel-e Bandage?

The FDA 510(k) record lists Gel-E, Inc. (Formerly Remedium Technologies, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gel-e Bandage?

The FDA product code for gel-e Bandage is KGN.

Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.